Nanochip Technology for B-Cell Lymphoma

Overseen By Lily Yang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Transformed lymphomas, CNS lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

73 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a special tiny chip to monitor treatment response and detect relapse in patients with diffuse large B-cell lymphoma by checking their blood for specific genetic markers. Rituximab has been a key component in treating diffuse large B-cell lymphoma.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is nanochip technology for B-cell lymphoma safe for humans?

The safety data for nanochip technology specifically is not available, but related technologies like CAR T-cell therapy, which also use advanced biotechnology, have shown a good safety profile in clinical trials for B-cell lymphoma, with no serious adverse events directly attributed to the treatment. ^{1 2 3 4 5}

How does the nanochip technology treatment for B-Cell Lymphoma differ from other treatments?

The nanochip technology treatment for B-Cell Lymphoma is unique because it uses biochips to detect a wide range of cell surface markers, allowing for precise identification and targeting of cancer cells. This method is different from traditional treatments as it provides a high level of accuracy and efficiency in diagnosing and potentially treating the disease by focusing on specific antigens present on the cancer cells. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Molecular Nanotechnology for B-Cell Lymphoma?

Research shows that nanotechnology can improve cancer treatments by making them more precise and reducing side effects. In particular, nanotechnology has been used to enhance drug delivery and treatment effectiveness for non-Hodgkin's lymphoma, which includes B-cell lymphoma. ^{1 11 12 13 14}

Who Is on the Research Team?

Beth Christian, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with a specific blood cancer called diffuse large B-cell lymphoma (DLBCL) who haven't been treated before. Participants must plan to get all their care at Ohio State University, aim for a cure with treatment, and go through 6 cycles of chemotherapy. They also need to be able to give consent.

Inclusion Criteria

You must plan to receive all treatment and follow-up care at Ohio State University (OSU).

I have a specific type of untreated lymphoma.

I am undergoing treatment aimed at curing my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo chemotherapy with ILN biochip testing before and after each course

Varies per participant

Multiple visits for each chemotherapy course

Monitoring

Participants' blood samples undergo ILN biochip testing every 3 months for 2 years to monitor treatment response and detect relapse

24 months

Every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Molecular Nanotechnology

Trial Overview The study is testing nanochip technology (ILN biochip) to see how well it can monitor the effectiveness of treatments in real-time and detect any return of the disease in patients with DLBCL. Researchers are looking for genetic markers that could predict treatment outcomes.

How Is the Trial Designed?

Group I: Diagnostic (ILN biochip testing) Experimental Treatment 1 Intervention

Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a phase 1 clinical trial involving 14 patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL), the novel Sleeping Beauty (SB) CD19-specific CAR T-cell therapy demonstrated a strong safety profile, with no serious adverse events directly linked to the treatment and only mild cytokine release syndrome observed.

Efficacy results showed that 38% of patients with ALL achieved complete remission or incomplete count recovery, and 50% of patients with diffuse large B-cell lymphoma (DLBCL) also achieved complete remission, indicating promising antitumor activity of the SB-based CAR constructs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies. Singh, H., Srour, SA., Milton, DR., et al.[2023]

CAR-T cell therapy shows promising efficacy in treating relapsed/refractory B-cell lymphoma, particularly in older patients and those with specific pathological types, achieving high response and complete remission rates across 17 studies.

While the treatment is generally safe, with most side effects like cytokine-releasing syndrome (CRS) and neurotoxicity being reversible, careful monitoring of these toxicities is essential during clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chimeric antigen receptor-T cells in the treatment of B cell lymphoma: a systematic review and meta-analysis. Zheng, XH., Zhang, XY., Dong, QQ., et al.[2023]

Chimeric antigen receptor (CAR) T-cell therapies have shown promising results in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma, offering complete and lasting clinical responses where traditional therapies have failed.

Four CD19-directed CAR T-cell therapies have been approved by the FDA for specific types of relapsed or refractory lymphomas, indicating a significant advancement in treatment options for these challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapsed/Refractory Non-Hodgkin Lymphoma: Engineering T-Cells to Express Chimeric Antigen Receptors (CARs), a Salvage? Kanwal, B.[2021]

In a phase I study involving 10 patients with refractory diffuse large B-cell lymphoma (DLBCL), the anti-CD19 CAR T cell therapy (C-CAR011) demonstrated a 50% overall response rate at 12 weeks, indicating promising efficacy for this treatment.

The therapy showed a favorable safety profile, with 90% of patients experiencing cytokine release syndrome but no severe (grade ⩾ 3) cases or neurotoxicity, suggesting it is a safe option for patients with heavily treated DLBCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of CBM.CD19 chimeric antigen receptor T cell in the treatment of refractory diffuse large B-cell lymphoma in Chinese patients. Fan, L., Wang, L., Cao, L., et al.[2022]

Citations

1. Greece pubmed.ncbi.nlm.nih.gov

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4. Netherlands pubmed.ncbi.nlm.nih.gov

Recent Advances in Nanobiotechnology for the Treatment of Non-Hodgkin's Lymphoma. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Potency Meets Precision in Nano-optimized Chemotherapeutics. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chimeric antigen receptor-T cells in the treatment of B cell lymphoma: a systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Relapsed/Refractory Non-Hodgkin Lymphoma: Engineering T-Cells to Express Chimeric Antigen Receptors (CARs), a Salvage? [2021]

9. China pubmed.ncbi.nlm.nih.gov

Phase I study of CBM.CD19 chimeric antigen receptor T cell in the treatment of refractory diffuse large B-cell lymphoma in Chinese patients. [2022]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Immunophenotype of neoplastic cells and its clinical significance in chronic lymphocytic leukemia]. [2016]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of biochips for immunomorphological diagnosis of chronic lymphocytic leukemia]. [2014]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Diagnostic microarrays in hematologic oncology: applications of high- and low-density arrays. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Immunodiagnosis of chronic lymphocytic leukemia using immunological chips. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Application of a miniature biochip using the molecular beacon probe in breast cancer gene BRCA1 detection. [2009]